Vivid i N ultrasound. Not marketed in the US. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal
Summary
The FDA issued a Class II for Vivid i N ultrasound. Not marketed in the US. Used in ultrasound imaging and by GE Medical Systems, LLC. Reason: Potential for batteries that have not been replaced at 2 years, as recommended in the Service Manual, they can fail or possibly emit smoke, or catch f.
Details
Source
Device Recall
External ID
Z-0758-2023
Action Date
2022-12-28
Status
Ongoing
Category
device
Product Description
Vivid i N ultrasound. Not marketed in the US. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal; Transrectal; Transvaginal; and Intraoperative (abdominal, thoracic, and vascular).
Lot/Code Info: No US Distribution. Model Number H45561AC, System ID: DZ1237US02, AO1015US01, EG1843US01, EG5882US01, EG1621US04, EG1621US03, 2538978U01, 083038042857318, 083038602007811, 083038602826113, 0835384095, IQ1165US05, IQ1376US01, KE1049US01, KW1010US04, KW1102US04, KW1001US35, KW1011US21, KW1011US22, KW1006US14, KW1098US06, KW1020US15, KT1061US01, KT1062US02, LB1359US04, 1553UL1026, 0834380243, 0834384085, 0834384095, MA1251US13, MA1272US10, OM1042US03, OM1007US11, OM1007US12, PK1331US08, PK1331US06, PA1097US01, SA1201US02, SA1014US07, SA1337US05, SA1060US08, SA1147US05, SA1149US03, SA1051US09, SA2220US02, SA2220US01, SA2072US17, SA1028US06, SA1089US07, SA1138US05, SA2158US07, SA1340US02, SA1223US15, SA1002US08, SA1036US06, SA1025US03, SA2214US03, SA1272US10, SA1024US04, SA1101US04, SA1034US20, SA1249US11, SA1034US23, SA1058US60, SA1058US47, SA1058US59, SA1332US03, SA1030US05, SA1282US05, ZA2573US01, ZA2422US01, ZA2328US01, ZA2339US01, ZA2420US01, ZA1024US07, ZA2348US01, ZA2358US01, ZA1030US10, ZA2421US01, ZA1025US16, ZA1025US25, ZA2378US01, ZA2510US01, TN1028US04, 01002ULT25, 06004ULT19, 07021ULT02, P34189UL17, 21002ULT18, 23002ULT06, P23003UL12, 32004ULT18, 34013ULT13, 34037ULT16, 34013ULT14, P35076UL03, 38006ULT08, 42002ULT12, 42002ULT10, P50005UL02, 55001ULT13, 60001ULT07, P61029UL05, AE1283US01, AE1353US01, AE1016US16, AE1016US14, AE1016US15, AE1011US18, AE1331US01, AE1015US16, YE1071US04, YE1071US03
Quantity Affected: 113 units
Reason for Recall
Potential for batteries that have not been replaced at 2 years, as recommended in the Service Manual, they can fail or possibly emit smoke, or catch fire.
Distribution
Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VI, VT, WA, WI, WV and the countries of Afghanistan, Albania, Algeria, Angola, Argentina, Armenia, Australia, Austria, AZERBAIJAN, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Bulgaria, Burkina Faso, Cambodia, Cameroon, Canada, Chile, CHINA Colombia, CONGO, Costa Rica, Cote D'Ivoire, Croatia, Cyprus, CZECH REPUBLIC, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Ethiopia, Finland, France, Georgia, Germany, Ghana, Greece, Guatemala, Honduras, HONG KONG, Hungary, ICELAND, INDIA, Indonesia, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Korea (Republic of), Kosovo, Kuwait, KYRGYZSTAN, Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, LUXEMBOURG, Macedonia, MALAYSIA, Mali, Mauritania, Mauritius, Mexico, MICRONESIA, Moldova, Morocco, Mozambique, Namibia, Nepal, Netherlands, NEW ZEALAND, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, SYRIA, TAIWAN, TANZANIA, THAILAND, Trinidad and Tobago, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Vietnam, Yemen.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-11-10
Company
Waukesha, WI
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 404 device recalls issued in the same week, part of 403 device-related FDA actions this month.
GE Medical Systems, LLC has 138 FDA actions in our database, including 121 recalls and 17 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (GE Medical Systems, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does GE Medical Systems, LLC have FDA actions?
GE Medical Systems, LLC has 138 FDA actions in our database, including 121 recalls and 17 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0758-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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